Olumiant Patient Information Including Side Effects

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Brand Names: Olumiant

Generic Name: baricitinib

What is baricitinib (Olumiant)?
What are the possible side effects of baricitinib (Olumiant)?
What is the most important information I should know about baricitinib (Olumiant)?
What should I discuss with my healthcare provider before taking baricitinib (Olumiant)?
How should I take baricitinib (Olumiant)?
What happens if I miss a dose (Olumiant)?
What happens if I overdose (Olumiant)?
What should I avoid while taking baricitinib (Olumiant)?
What other drugs will affect baricitinib (Olumiant)?
Where can I get more information (Olumiant)?

What is baricitinib (Olumiant)?

Baricitinib blocks the activity of certain enzymes involved in activating inflammation in the body.

Baricitinib is used to reduce pain, stiffness, and swelling in adults with rheumatoid arthritis after other treatments have failed. Baricitinib also helps slow the progression of bone and joint damage.

Baricitinib may also be used for purposes not listed in this medication guide.

What are the possible side effects of baricitinib (Olumiant)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

fever, chills, sweating;
skin sores;
tiredness, muscle pain;
increased urination, pain or burning when you urinate;
stomach pain, diarrhea, weight loss; or
cough, shortness of breath, coughing up pink or red mucus.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

shingles--burning pain, numbness, tingling, itching, skin rash or blisters;
signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
signs of a blood clot in your leg--swelling, warmth, or redness in an arm or leg;
signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits; or
signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

sores on your lips (cold sores);
nausea; or
cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about baricitinib (Olumiant)?

Baricitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

You should not start taking baricitinib if you have any kind of infection. Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer

Olumiant Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking baricitinib (Olumiant)?

You should not use baricitinib if you are allergic to it, or if you have any kind of infection.

Tell your doctor if you have ever had:

a chronic infection;
liver or kidney disease;
hepatitis B or C;
a stomach or intestinal problem such as diverticulitis or an ulcer;
a perforation (a hole or tear) in your esophagus, stomach, or intestines;
a blood clot;
cancer;
low white or red blood cell counts; or
if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Using baricitinib may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using baricitinib.

How should I take baricitinib (Olumiant)?

Before you start treatment with baricitinib, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take baricitinib with or without food.

Baricitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture and heat.

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow

Olumiant Patient Information including If I Miss a Dose

What happens if I miss a dose (Olumiant)?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose (Olumiant)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking baricitinib (Olumiant)?

Do not receive a "live" vaccine while using baricitinib. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect baricitinib (Olumiant)?

Tell your doctor about all your other medicines, especially:

methotrexate;
probenecid;
steroid medicine such as prednisone or dexamethasone;
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
other drugs to treat rheumatoid arthritis--abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab, tofacitinib.

This list is not complete. Other drugs may affect baricitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information (Olumiant)?

Your pharmacist can provide more information about baricitinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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